For much of the last two years, Democratic state Sen. David Zuckerman of Vermont thought he was victorious. For more than a decade, the organic farmer had tried to force companies that sell food in his state to label products that include genetically modified organisms (GMOs).

His legislative colleagues finally agreed to his proposal in 2014, and the law took effect this July. But just weeks after it did, the U.S. Congress nullified it by passing a less restrictive federal labeling law.

Congress’ point, Zuckerman said, was not to encourage more food labeling nationwide, it was “to override Vermont’s law.” It also was meant to halt the spread of state labeling laws that could be in conflict with each other or require food companies to label products differently from state to state.

Although the federal government has set national standards for food, air and water quality, Congress typically leaves much of the policymaking that can affect environmental public health, such as auto emission inspections and wastewater treatment, to the states.

But as the food labeling law illustrates, Congress increasingly is stepping in on environmental health issues — at the urging of affected industries — to prevent a patchwork of state laws and regulations by setting national standards. In the last 12 months, Congress also signed a ban on plastic microbeads in cosmetics and an update to the 40-year-old Toxic Substances Control Act. [Read more…]

At first, Vincent Karst, 55, was recovering well from his open-heart surgery in March 2015.

He resumed the activities he enjoyed, such as visiting car shows and eating out. But some months later, his condition mysteriously deteriorated. By fall he was so short of breath, nauseated and overwhelmed by fatigue that he needed to be rehospitalized in York, Pa.

There, doctors diagnosed a new problem: a serious mycobacterial infection that was acquired during his surgery, according to his subsequent lawsuit. Aggressive treatment with antibiotics left him with partial hearing and vision loss.

Federal regulators acknowledge they were aware of infections tied to a heart-surgery device used in Karst’s operation by the summer of 2014.

But they waited 14 months before issuing a public alert about the risks, and it wasn’t until last month — more than two years later — that they issued detailed recommendations to hospitals and patients on what to do.

Critics say a swifter response could have saved thousands of patients like Karst from being exposed to potentially deadly bacteria. Some patients fell ill or died without knowing the real cause, doctors say. [Read more…]

A 14-year-old dying girl has won the right to have her body cryonically preserved immediately after she died, according to a recent UK High Court decision.

The girl, known as JS, hoped that sometime in the future, when doctors found a cure for her cancer, she might be brought back to life.

She had spent several months researching the science of cryonics and the judge had no doubt that she had sound capacity when making her decision.

The judge noted that under the UK’s Human Tissue Act cryonics is not illegal. However, it is unregulated.

The closest the act comes to cryonics is regulating the freezing of sperm and embryos, in the form of cryopreservation. The judge did, however, acknowledge the need for new legislation relating to cryonics.

But how realistic is cryonics’ chance of success? Is it a nonsensical waste of money and resources, selling snake oil for hope in dying patients? Or is it the new frontier of modern medical science, the path to post-humanism?

What type of world will the girl at the centre of the latest court case wake up to?

Mitochondrial replacement or donation allows women who carry mitochondrial diseases to avoid passing them on to their child. These diseases can range from mild to life-threatening. No therapies exist and only a few drugs are available to treat them.

There are no international rules regulating this technique. Just one country, the United Kingdom, explicitly regulates the procedure. It’s a similar situation with other assisted reproductive techniques. Some countries permit these techniques and others don’t. [Read more…]

Federal regulators said 12 U.S. hospitals, including well-known medical centers in Los Angeles, Boston and New York, failed to promptly report patient deaths or injuries linked to medical devices.

The Food and Drug Administration publicly disclosed the violations in inspection reports this week amid growing scrutiny of its ability to identify device-related dangers and protect patients from harm.

Some of the reporting lapses were found at Massachusetts General Hospital in Boston, NewYork-Presbyterian Hospital and two hospitals in Los Angeles — the Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center. [Read more…]

An acute need for more and easier access to mental health treatment and improvements in communications technology have set off a boom in remote therapy, but strict licensing rules and varying state laws are hampering its growth.

Like telehealth in general, using videoconferencing, smartphones and other technology to treat mental illness has long been recognized as an invaluable tool for getting care to people in rural areas, where shortages of psychiatrists, psychologists and other providers are even more acute than in the rest of the nation.

Now, telemental therapy — also called virtual therapy, telepsychiatry or telebehavioral health — is more widely available outside of rural areas and is seen as a way to address two crises that aggravate each other.

Clinical trials have been the gold standard of scientific testing ever since the Scottish naval surgeon Dr James Lind conducted the first while trying to conquer scurvy in 1747. They attract tens of billions of dollars of annual investment and researchers have published almost a million trials to date according to the most complete register, with 25,000 more each year.

Clinical trials break down into two categories: trials to ensure a treatment is fit for human use and trials to compare different existing treatments to find the most effective. The first category is funded by medical companies and mainly happens in private laboratories.

The second category is at least as important, routinely informing decisions by governments, healthcare providers and patients everywhere. It tends to take place in universities. The outlay is smaller, but hardly pocket change. For example, the National Institute of Health Research, which coordinates and funds NHS research in England, spent £74m ($91m) on trials in 2014/15 alone.

Yet there is a big problem with these publicly funded trials that few will be aware of: a substantial number, perhaps almost half, produce results that are statistically uncertain. If that sounds shocking, it should do. A large amount of information about the effectiveness of treatments could be incorrect. How can this be right and what are we doing about it? [Read more…]

Spending was driven by increases in drug unit prices rather than an increase in the volume of drugs used, they found.

“It would be one thing if price increases were associated with clear and important clinical improvements, but they’re not,” Chip Kahn, CEO of the federation, said Tuesday in a press briefing.

The price hikes driving the spending increases “appear to be random and inconsistent from one year to the next,” the researchers wrote. About half of the drug price hikes in the report occurred in drugs with no generic competitors. [Read more…]

For those of you whose lives — or whose loved ones’ lives — have been upended by chronic or incurable conditions such as Parkinson’s, that’s just the kind of breakthrough you’ve been waiting for.

But today, I’m going to pass along some advice about these and other for-profit stem cell treatments that you probably don’t want to hear: “Steer clear of them. They’re probably taking advantage of you and it’s probably unproven,” says Lawrence Goldstein, director of the Sanford Stem Cell Clinical Center at UC San Diego Health.

Stem cell science is a relatively new field. Stem cells hold great potential for medicine because of their ability to develop into different types of cells in the body, and to repair and renew tissue.

But so far, the only stem cell treatments approved for wide use in the U.S. involve stem cell transplants from bone marrow or blood for patients with certain cancers and other disorders, says Sidney Golub, director of the Sue and Bill Gross Stem Cell Research Center at the University of California, Irvine.

Meanwhile, dozens of experimental stem cell treatments are being tested across the country in clinical trials on human subjects.

“There are some really exciting developments showing great promise, but they are unproven at present,” Golub says. [Read more…]

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